QUAPELLA (QUAlity of Prostate Enucleation by LUMENIS - Laser)

NCT01534793 | Completed

• 2 other identifiers: K070301 / IC07092008-A-00498-47
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.

Conditions

Benign Prostatic Hyperplasia

Keywords

Quality assessment; Benign Prostatic Hyperplasia; Enucleation of the prostate; LUMENIS; Laser; Learning Curve

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale [varying from 0 to 5].

  The primary outcome is the ability of each surgeon to perform 4 HoLEP procedures successfully, according to a pre-defined surgical performance scale \[varying from 0 to 5\]. To be successful, a procedure must be scored 5/5. Each procedure is evaluated at the end of the surgical act by the surgeon himself.

  participants will be followed for the duration of the intervention, an expected average of 1 hour

Secondary Outcomes (25)

• I-PSS symptom score (15 days before operation, at 6 and 12 months postoperative)

  15 days before operation, at 6 and 12 months postoperative)

• I-PSS bother score (15 days before operation, at 1, 6 and 12 months postoperative)

  15 days before operation, at 1, 6 and 12 months postoperative

• DAN-PSSsex score (15 days before operation, at 6 and 12 months postoperative)

  15 days before operation, at 6 and 12 months postoperative

• Global sexual satisfaction (15 days before operation, at 6 and 12 months postoperative)

  15 days before operation, at 6 and 12 months postoperative

• Quality of life score QoL-Europe (15 days before operation, and at 12 months postoperative)

  15 days before operation, and at 12 months postoperative

Study Arms (1)

HoLEP

Holmium Laser Enucleation of the Prostate

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Interventions

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

Under regional or general anaesthesia Urethroscopy to check the location of the prostatic capsule Enucleation of the prostatic lobes (median if present, then lateral lobes)Hemostasis Morcellation Device : LUMENIS Laser

HoLEP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia

You may qualify if:

• Male patients over 50
• Classification of risk according to the American Society of Anesthesiologists (ASA) score: score 1, 2 or 3
• Protocol accepted by patient (signed informed consent)
• Patient presenting low urinary tract symptoms due to benign prostatic hyperplasia, since at least 3 months, with indication of surgical relief of bladder outlet obstruction , with International prostate symptom score (I-PSS)≥ 12 and a bother score ≥ 3, or full bladder retention, drained by a catheter or suprapubic catheter
• Patient with maximum urinary flow rate ≤ 12mL/s for a voiding volume ≥ 125mLat uroflowmetry, for patients who are not drained
• Prostate weight between 40 and 80 grams
• Post void residual volume ≤ 300cc, for patients who are not drained
• Normal renal function
• Non suspect digital rectal examination
• PSA value et blood test £ 4 ng/ml, or negative prostatic biopsies if PSA comprised between 4 and 10 ng/ml for patients with age \< 75 and life expectancy \> 10 years
• Patient under oral anticoagulation therapy if a therapeutic switch is possible and validated by both the anaesthesiologist and the prescription of the anticoagulation therapy
• Patient under under antiplatelet agents if this treatment can be interrupted without replacement therapy 5 days prior to surgery without any increased risk for the patient safety
• Patient gave informed consent and is not opposed to the use of the data collected during the study for research purpose
• Patient treated by BPH drugs if the duration and type are known, and if the treatment has been stopped before the intervention (one week before surgery for plants and alpha-blockers, one week for 5-alpha reductase inhibitors)
• Patients has valid health insurance/coverage.

You may not qualify if:

• Patients with unstable known cardiac or pulmonary disease
• Patients with severe myasthenia, multiple sclerosis, Parkinson disease with known bladder or urinary sphincter dysfunction.
• Patient with history of severe pelvic injury having caused severe external urinary sphincter damage.
• Patient with active urinary tract infection
• Patient with urinary catheter or a suprapubic catheter for a reason other than acute urinary retention due to benign prostatic hyperplasia or experiencing no need to urinate after an event filling than 300cc
• Patient with neurogenic disease of the urinary tract
• Patient with known or suspected malignant lesion of the bladder or the prostate
• Patient with history of previous prostatic surgery
• Patient with history of bladder stone, major hematuria, urethral stricture, bladder neck stenosis, bladder disease or diabetes with bladder impairment
• Patient with a prosthesis or material in the region potentially affected by the surgical procedure.
• Patient with ano-rectal disease
• Cases where the surgical indication is decided in an emergency context
• Patient with predictable incomplete follow-up

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service Urologie - Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bertrand LUKACS, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 17, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2014
• Last Updated: February 25, 2015

Record last verified: 2015-02

Locations

FR (1)